A PHASE-II CONTROLLED-STUDY OF A COMBINATION OF THE IMMUNE MODULATOR,LENTINAN, WITH DIDANOSINE (DDI) IN HIV PATIENTS WITH CD4 CELLS OF 200-500 MM(3)/

This study was carried out to assess the safety and efficacy of a comb ination of lentinan, an immune modulator, and didanosine (ddI) in a co ntrolled study in HIV positive patients with CD4 levels of 200-500 cel ls/mm(3). Didanosine was administered to HIV patients at doses of 400 mg/day (po) fur six weeks (bid), then 2 mg of lentinan i.v. was added per week for 24-80 weeks. A control group (20%) received ddI only. A t otal of 107 patients were enrolled at three sites, and 88 patients sta rted the ddI/lentinan phase. The combination caused significant increa ses in CD4 levels up to 38 weeks, whereas ddI alone was significant at the 5% level at 14 weeks. Based on these data, lentinan qualifies as a participant in future multi-drug studies in HIV.